Patent Law

ACLU Mob Attacks Breast Cancer Test Patent

By Stephen Albainy-Jenei

The American Civil Liberties Union (ACLU), the Public Patent Foundation (PUBPAT), and a whole host of others have filed a lawsuit challenging patents on two human genes associated with breast and ovarian cancer claiming such patents stifle research that could lead to cures and limit women’s options regarding their medical care.

Mutations along the genes, known as BRCA1 and BRCA2, are responsible for most cases of hereditary breast and ovarian cancers.  The suit claims that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes.  The plaintiffs in the lawsuit include several patients and more than a dozen universities, genetic specialists and medical associations, such as the Association for Molecular Pathology and the American College of Medical Genetics.

Since the U.S. Patent and Trademark Office (PTO) granted patents on the BRCA genes to Myriad Genetics, Myriad?s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad?s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests ? over $3,000, which is too expensive for some women to afford.

The ACLU says that patenting the genes limits research and the free flow of information, and as a result violates the First Amendment.  The lawsuit challenges genetic patenting in general, noting that about 20 percent of all human genes are patented — including genes associated with Alzheimer’s disease, muscular dystrophy and asthma.

As these things usually go, the issue is not that Myriad has a patent and is keeping withheld from patients.  The issue is that Myriad is charging as much as $3,000 a test, possibly keeping some women from seeking preventative genetic testing.  The question might be better framed as “Who should pay for health care costs as expensive diagnostics come available?”  In addition, what we can do to address health care costs that are spiraling out of control?

Medical breakthrough receive patent protection, which allows the patent-holder to charge higher prices. High prices yield high profits, which creates an incentive to develop the next generation of therapeutics and diagnostics.  On top of that, neither the service provider nor the patient gets the bill leaving cost containing to the insurance companies. These are all difficult issues to reconcile.

Attorneys on the case include Hansen and Aden Fine of the ACLU First Amendment Working Group; Lapidus and Park of the ACLU Women’s Rights Project; and Ravicher of PUBPAT.  Simoncelli, the ACLU’s science advisor, provides expert guidance on the case.

Plaintiff and supporter statements and a copy of the complaint can be found here.

More information, including a video of why we’re fighting to liberate the breast cancer genes, plaintiff and supporter statements and a copy of the complaint, is here.

A copy of the complaint is here: myriad-brca1-complaint (pdf)

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Full post as published by Patent Baristas on May 14, 2009 (boomark / email).